FDA Recall D-1500-2022
Vi-Jon, LLC · Smyrna, TN
Class I — life-threatening Terminated 664 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428 30594 2; b) UPC 0 50428 33517 8; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Reason for recall
Microbial contamination of non-sterile products.
Recall record
- Recall number
D-1500-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed Nationwide in the USA as well as Canada and Panama.
- Recall initiated
- 2022-07-15
- Classified by FDA Center
- 2022-09-09
- FDA published
- 2022-09-21
- Terminated
- 2024-05-09
- Recalling firm
- Vi-Jon, LLC
- Firm location
- Smyrna, TN